NCT01809379

Brief Summary

This trial aims to assess efficacy and safety of an intraperitoneal, aerosol, high-pressure chemotherapy in women with recurrent ovarian cancer

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 8, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

1.1 years

First QC Date

March 8, 2013

Last Update Submit

July 7, 2022

Conditions

Recurrent Ovarian Cancer

Keywords

ovarian cancer, recurrent, chemotherapy, intraperitoneal

Outcome Measures

Primary Outcomes (1)

  • Clinical Benefit Rate

    The clinical benefit rate comprises complete remission, partial remission, and stable disease according to RECIST criteria.

    6 months

Secondary Outcomes (1)

  • safety

    6 months

Other Outcomes (1)

  • tumor apoptosis assessment, videolaparoscopy assessment of response, CA 125 assessment of response

    6 months

Study Arms (1)

intraperitoneal chemotherapy

EXPERIMENTAL

Intraperitoneal chemotherapy with cisplatin at a dose of 7.5 mg/m2 body surface in a 150 ml NaCl 0.9% and doxorubicin at a dose of 1.5 mg/m2 body surface in a 50 ml NaCl 0.9% solution with a flow of 30 ml/min and a max upstream pressure of 200 psi.

Drug: chemotherapy with doxorubicin and cisplatin

Interventions

chemotherapy with doxorubicin and cisplatinDRUG

intraperitoneal chemotherapy applied as an aerosol and under pressure

Also known as: CISPLATIN Teva, Adrimedac
intraperitoneal chemotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 2 lines of previous chemotherapy
  • recurrent ovarian cancer
  • patient is mobile
  • informed consent

You may not qualify if:

  • ileus
  • necessity of parenteral nutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruhr University Bochum

Bochum, North Rhine-Westphalia, 44623, Germany

Location

Related Publications (1)

  • Tempfer CB, Winnekendonk G, Solass W, Horvat R, Giger-Pabst U, Zieren J, Rezniczek GA, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy in women with recurrent ovarian cancer: A phase 2 study. Gynecol Oncol. 2015 May;137(2):223-8. doi: 10.1016/j.ygyno.2015.02.009. Epub 2015 Feb 18.

    PMID: 25701703RESULT

MeSH Terms

Conditions

Ovarian NeoplasmsRecurrence

Interventions

Drug TherapyDoxorubicinCisplatin

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Clemens Tempfer, MD

    Runr University Bochum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Clemens Tempfer, MBA

Study Record Dates

First Submitted

March 8, 2013

First Posted

March 12, 2013

Study Start

February 1, 2013

Primary Completion

March 1, 2014

Study Completion

September 1, 2014

Last Updated

July 8, 2022

Record last verified: 2022-07

Locations

DE(1)